OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Premarket Approval P940010 S014

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Replace the current final diffuser tip axial load test method with a test method that is currently performed as an in-process diffuser tip axial load test and to eliminate the requirement for an in-process diffuser tip axial load test.

DeviceOPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)
Classification NameSystem, Laser, Fiber Optic, Photodynamic Therapy
Generic NameSystem, Laser, Fiber Optic, Photodynamic Therapy
ApplicantCONCORDIA LABORATORIES, INC
Date Received2018-01-16
Decision Date2018-01-30
PMAP940010
SupplementS014
Product CodeMVG
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address CONCORDIA LABORATORIES, INC 5 Canewood Industrial Park st Michael BB110

Supplemental Filings

Supplement NumberDateSupplement Type
P940010Original Filing
S017 2020-11-02 Real-time Process
S016 2018-12-19 Normal 180 Day Track
S015 2018-04-03 Real-time Process
S014 2018-01-16 30-day Notice
S013 2017-12-18 30-day Notice
S012 2017-10-24 Real-time Process
S011 2013-09-13 Real-time Process
S010 2002-06-12 Panel Track
S009 2000-04-17 Normal 180 Day Track
S008 1999-09-21 Normal 180 Day Track
S007 1999-07-08 Normal 180 Day Track
S006 1999-02-08 Normal 180 Day Track
S005 1998-08-21 Normal 180 Day Track
S004 1998-03-24 Normal 180 Day Track
S003 1997-02-18 Normal 180 Day Track
S002 1997-02-10 Normal 180 Day Track
S001 1996-07-03 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00376128000087 P940010 000
00376128000148 P940010 000
00376128000131 P940010 000
00376128000124 P940010 000
00376128000117 P940010 000
00376128000100 P940010 000
00376128000094 P940010 000
00376128000278 P940010 001
00376128000261 P940010 001
00376128000254 P940010 001
00376128000247 P940010 001
00376128000230 P940010 001
00376128000223 P940010 001
00376128000148 P940010 001
00376128000087 P940010 001
00376128000131 P940010 001
00376128000124 P940010 001
00376128000117 P940010 001
00376128000100 P940010 001
00376128000094 P940010 001
00376128000070 P940010 011
00376128000063 P940010 011
00376128000049 P940010 011
00376128000032 P940010 011
00376128000025 P940010 011
00376128000018 P940010 011
00376128000056 P940010 011
00376128000346 P940010 016
00376128000353 P940010 016
00376128000360 P940010 016
00376128000377 P940010 016
00376128000391 P940010 016
00376128000384 P940010 016

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.